Treating Tinnitus Using the Neuromonics Tinnitus Treatment Program: A Randomized, Double-blind Study

NCT02829073 | Unknown

• 1 other identifier: USAARL 2014-045; IRB M-10464
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The most current data indicate that tinnitus and hearing impairment are the Number 1 and 2 disabilities associated with service in Operations Iraqi Freedom and Enduring Freedom. Tinnitus can result from exposure to continuous noise from vehicles, generators, and other equipment, and from blast, or impulse noise from friendly-or opposing-forces weapon systems. Thus, tinnitus caused by both long-term noise exposure and acute acoustic trauma is an obstacle to be overcome in return-to-duty decisions and represents a serious liability to the retention of a healthy and fit force. Until recently, there has been no treatment that has been clinically validated as consistently effective. The development of the Neuromonics Tinnitus Treatment sought to overcome the practical limitations of previously available approaches (e.g. tinnitus maskers and biofeedback). While these studies have demonstrated the efficacy of the Neuromonics Tinnitus Treatment over alternative therapies, these trials studied target populations that may not be representative of the typical Soldier experiencing tinnitus. One hundred and twenty (120) Soldiers or veterans with debilitating tinnitus will be recruited and divided into groups treated with two treatments, the Neuromonics Tinnitus Treatment Program which includes the use of the Neuromonics Oasis™ treatment device and a similarly-treated device using a placebo treatment. The study uses a randomized, double-blind design. The effectiveness of the treatments will be assessed using standard audiometric procedures and tinnitus subjective questionnaires. This study will allow the Office of the Surgeon General of the Army to provide direction regarding the Neuromonics Tinnitus Treatment Program (NTTP) for alleviation of debilitating tinnitus that adversely affects Soldier deployability and operational performance. Retention of a fit force and improved quality of life for active-duty Soldiers are important issues associated with a successful approach to the treatment of tinnitus.

Conditions

Tinnitus

Keywords

Tinnitus; Double-blind; Neuromonic Tinnitus Treatment Program; Oasis™

Outcome Measures

Primary Outcomes (1)

• Tinnitus Reaction Questionnaire (TRQ)

  Change in TRQ score at 6 months compared to baseline

  Baseline and two, four, and six months after enrollment

Secondary Outcomes (7)

• Tinnitus Reaction Questionnaire (TRQ) Midterm

  Baseline and two, four, and six months after enrollment

• Tinnitus Reaction Questionnaire (TRQ) Awareness

  Baseline and two, four, and six months after enrollment

• Tinnitus Reaction Questionnaire (TRQ) Bothersome

  Initial and two, four, and six months after enrollment

• PTSD Checklist-Military (PCL-M)

  Baseline and two, four, and six months after enrollment

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and six months after enrollment

Study Arms (2)

Oasis™ device

EXPERIMENTAL

Treatment using the Neuromonics Tinnitus Treatment Program and the Neuromonics Oasis™ treatment device.

Device: Neuromonics Tinnitus Treatment Program

Placebo device

PLACEBO COMPARATOR

Treatment using the Neuromonics Tinnitus Treatment Program and an identical-appearing placebo device.

Device: Placebo Device

Interventions

Neuromonics Tinnitus Treatment Program DEVICE

The Neuromonics Oasis™ treatment device will be fit to individuals reporting significant tinnitus. Assessment of primary and secondary measures will be made at 0 and 6 months following fitting.

Also known as: Neuromonics Oasis™ treatment device

Oasis™ device

Placebo Device DEVICE

A placebo device, identical to the Neuromonics Oasis™ device with altered firmware will be fit to individuals reporting significant tinnitus. Assessment of primary and secondary measures will be made at 0 and 6 months following fitting.

Placebo device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If an active duty military personnel, must be between the ages of 18 to 60 years at the time of enrollment.
• If a veteran, must be between the ages of 19 to 60 years at the time of enrollment
• Tinnitus disturbance determined at the initial pre-enrollment assessment to be clinically significant, as denoted by a score on the TRQ of 17-70; and
• Four frequency (0.5, 1, 2, and 4 kHz) pure tone average in one ear (0.5, 1, 2, and 4 kHz) is equal to or less than 50dB HL, as determined by audiometry performed at the initial pre-enrollment assessment; and
• Cognitive, comprehension and manual dexterity abilities sufficient to self-administer treatment, and ability to travel to attend appointments, as necessary, as determined at the initial pre-enrollment assessment; and
• Motivated to pursue treatment and has appropriate expectations as to treatment outcomes (including the possibility of being assigned to the placebo group), as determined at the initial pre-enrollment assessment.
• Must have access to healthcare for follow-up care for the six month study period

You may not qualify if:

• Refusal to give consent
• Significant psychological disturbance \[defined as any rating other than 0 on Question Number 24 the TRQ (suicidal ideology) or a score of more than 78 on the Tinnitus Handicap Inventory (THI)\] that may interfere with the treatment as assessed by the treating clinician and/or referring physician;
• Complicating medical conditions such as acute/unstable Meniere's disease as inferred by responses on the Tinnitus History Questionnaire (THQ);
• Ongoing use of ototoxic medications (THQ);
• Pulsatile tinnitus (THQ);
• Continued excessive noise exposure without effective hearing protection (THQ);
• After all elements of informed consent are completed and the TRQ has been scored, a score of less than 17 will exclude the volunteer from participation.

Sponsors & Collaborators

• United States Army Aeromedical Research Laboratory: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

U.S. Army Aeromedical Research Laboratory

Fort Rucker, Alabama, 36362-0577, United States

RECRUITING

Related Publications (20)

• Davis PB, Paki B, Hanley PJ. Neuromonics Tinnitus Treatment: third clinical trial. Ear Hear. 2007 Apr;28(2):242-59. doi: 10.1097/AUD.0b013e3180312619.

  PMID: 17496674 BACKGROUND

• Davis PB, Wilde RA, Steed LG, Hanley PJ. Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study. Ear Nose Throat J. 2008 Jun;87(6):330-9.

  PMID: 18561116 BACKGROUND

• Hanley PJ, Davis PB, Paki B, Quinn SA, Bellekom SR. Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: clinical outcomes in general private practice. Ann Otol Rhinol Laryngol. 2008 Nov;117(11):791-9. doi: 10.1177/000348940811701101.

  PMID: 19102123 BACKGROUND

• Karch, S.J., et al., Evaluation of Sound Therapy Tinnitus Treatments with Concurrent Counseling in Active Duty Military Personnel. 2014, U.S. Army Aeromedical Research Laboratory: Fort Rucker, AL.

  BACKGROUND

• Bauer CA, Brozoski TJ. Effect of gabapentin on the sensation and impact of tinnitus. Laryngoscope. 2006 May;116(5):675-81. doi: 10.1097/01.MLG.0000216812.65206.CD.

  PMID: 16652071 BACKGROUND

• Tyler RS, Baker LJ. Difficulties experienced by tinnitus sufferers. J Speech Hear Disord. 1983 May;48(2):150-4. doi: 10.1044/jshd.4802.150.

  PMID: 6621006 BACKGROUND

• Jastreboff PJ, Hazell JW. A neurophysiological approach to tinnitus: clinical implications. Br J Audiol. 1993 Feb;27(1):7-17. doi: 10.3109/03005369309077884.

  PMID: 8339063 BACKGROUND

• Henry JA, Schechter MA, Loovis CL, Zaugg TL, Kaelin C, Montero M. Clinical management of tinnitus using a "progressive intervention" approach. J Rehabil Res Dev. 2005 Jul-Aug;42(4 Suppl 2):95-116. doi: 10.1682/jrrd.2005.01.0005.

  PMID: 16470467 BACKGROUND

• Dineen R, Doyle J, Bench J, Perry A. The influence of training on tinnitus perception: an evaluation 12 months after tinnitus management training. Br J Audiol. 1999 Feb;33(1):29-51. doi: 10.3109/03005364000000098.

  PMID: 10219721 BACKGROUND

• Hiller W, Haerkotter C. Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther. 2005 May;43(5):595-612. doi: 10.1016/j.brat.2004.03.012.

  PMID: 15865915 BACKGROUND

• Moffat G, Adjout K, Gallego S, Thai-Van H, Collet L, Norena AJ. Effects of hearing aid fitting on the perceptual characteristics of tinnitus. Hear Res. 2009 Aug;254(1-2):82-91. doi: 10.1016/j.heares.2009.04.016. Epub 2009 May 3.

  PMID: 19409969 BACKGROUND

• Karch, S. J., Hill, M. M., Casto, K. L., Nedostup, A. E., & Staton, R. N. (2014). Evaluation of Sound Therapy Tinnitus Treatments with Concurrent Counseling in Active Duty Military Personnel. (Report 2014-022). Fort Rucker, AL: U.S. Army Aeromedical Research Laboratory.

  BACKGROUND

• US Department of Veterans Affairs. (2010). 2010 Annual Benefits Report. Retrieved from www.vba.va.gov/REPORTS/abr/2010_abr.pdf.

  BACKGROUND

• McKinney, C.J., J.W. Hazell, and R.L. Graham, An evaluation of the TRT method, in Proceedings of the sixth international tinnitus seminar, J.W. Hazell, Editor. 1999. p. 99-105.

  BACKGROUND

• Schmitt, C. and B. Kroner-Herwig, Comparison of tinnitus coping training and TRT: Are they superior to education?, in Proceedings of the Seventh International Tinnitus Seminar, R. Patuzzi, Editor. 2002, Hawthorn Production Services: Norfolk, VA. p. 273-276.

  BACKGROUND

• Tyler, R.S., Final Report: A preliminary investigation of the effectiveness of tinnitus retraining therapy. Tinnitus Today, 2004. 29: p. 12.

  BACKGROUND

• Henry, J.A., et al., Tinnitus retraining therapy and masking; how do they compare?, in Proceedings of the Seventh International Tinnitus Seminar, R. Patuzzi, Editor. 2002, Hawthorn Production Services: Norfolk, VA. p. 247-254.

  BACKGROUND

• Tyler, R.S., Neurophysiological models, psychological models, and treatments for tinnitus, in Tinnitus Treatments: Clinical Protocols, R.S. Tyler, Editor. 2005, Thieme Medical Publishers: New York. p. 1-22.

  BACKGROUND

• Davis, P.B., R.A. Wilde, and L.G. Steed. Clinical trial findings of a neurophysiologically-based tinnitus rehabilitation technique using tinnitus desensitization music. in Proceedings of the Seventh International Tinnitus Seminar. 2002. Perth: University of Western Australia.

  BACKGROUND

• Davis, P.B., Music and the acoustic desensitization protocol for tinnitus., in Tinnitus treatments R.S. Tyler, Editor. 2005, Thieme: New York.

  BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William A Ahroon, Ph.D.

  U.S. Army Aeromedical Research Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist (Research)

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 12, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)